Trial to Evaluate UltraSound in the Treatment of Tibial Fractures (TRUST)

This study has been terminated.
(Study was terminated due to futility)
Sponsor:
Collaborators:
McMaster University
Clinical Advances Through Research and Information Translation
Information provided by (Responsible Party):
Bioventus LLC
ClinicalTrials.gov Identifier:
NCT00667849
First received: April 21, 2008
Last updated: November 4, 2015
Last verified: November 2015
Results First Received: September 24, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Tibial Fractures
Interventions: Device: Exogen 4000+
Device: Sham

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Exogen 4000+

Single arm, Exogen 4000+

Low-intensity pulsed ultrasound (LIPUS)

Sham

Single arm, sham (identical to active device with the exception of administration of ultrasound)

Sham: sham device identical to active device with the exception of administration of ultrasound


Participant Flow:   Overall Study
    Exogen 4000+     Sham  
STARTED     250     251  
COMPLETED     142     130  
NOT COMPLETED     108     121  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Exogen 4000+

Single arm, Exogen 4000+

Low-intensity pulsed ultrasound (LIPUS)

Sham

Single arm, sham (identical to active device with the exception of administration of ultrasound).

Sham: sham device identical to active device with the exception of administration of ultrasound

Total Total of all reporting groups

Baseline Measures
    Exogen 4000+     Sham     Total  
Number of Participants  
[units: participants]
  250     251     501  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     244     239     483  
>=65 years     6     12     18  
Age  
[units: years]
Mean (Standard Deviation)
  37.1  (13.2)     39.1  (14.6)     38.3  (13.9)  
Gender  
[units: participants]
     
Female     81     75     156  
Male     169     176     345  
Region of Enrollment  
[units: participants]
     
Canada     82     85     167  
United States     168     166     334  



  Outcome Measures
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1.  Primary:   Change From Baseline in the SF-36 Physical Component Summary (PCS) Score of the Short Form-36 (SF-36)   [ Time Frame: Over 365 days ]

2.  Primary:   Time (Days) to Radiographic Healing of Tibial Fractures   [ Time Frame: over 365 days ]

3.  Other Pre-specified:   Treatment Compliance   [ Time Frame: Treatment period: Days from randomization to day of x-ray assessed healed or, if not heal, day of premature withdrawal/study termination or day 365 (end of study visit) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Poor Compliance: Protocol defined compliance as ≥18 minutes use per day. Devices have a treatment monitor that showed average compliance of 42.3% (sham) and 44.6% (active) in 80% of treatment days. Poor treatment adherence confounds results.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Peter Heeckt, MD (CMO)
Organization: Bioventus LLC
phone: 1-800-396-4325
e-mail: peter.heeckt@bioventusglobal.com


No publications provided by Bioventus LLC

Publications automatically indexed to this study:

Responsible Party: Bioventus LLC
ClinicalTrials.gov Identifier: NCT00667849     History of Changes
Other Study ID Numbers: EX-TIB-0907
Study First Received: April 21, 2008
Results First Received: September 24, 2015
Last Updated: November 4, 2015
Health Authority: United States: Food and Drug Administration
Canada: Canadian Institutes of Health Research